FDA recall Z-0709-2025

Product

mint Lesion, Software Versions: 3.9.0 through 3.9.5.

Reason for recall

Some software versions have a malfunction where they may show incorrect orientation labels for a specific subset of DICOM images.

Distribution

Worldwide distribution: US (nationwide): AR, CA, FL, GA, MI, MN, NY, OH, PA, TN, TX, WI; and OUS (International) to countries of: Austria, Belgium, France, Germany, Italy, Netherlands, Spain, Switzerland, United Kingdom.

Key facts

Status

Ongoing

Initiation date

2024-11-15

Report date

2024-12-25

Voluntary/Mandated

Voluntary: Firm initiated

Location

Dossenheim, Germany

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0709-2025